HealthyPhase 1NCT01016626
Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet
A Phase 1 study testing CKD-4101 tablet and Mycophenolate Mofetil capsule in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CKD-4101 tablet and Mycophenolate Mofetil capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20 aged and 45 aged in healthy males
- Weight more than 45 kg, IBW ± 20% within the range
- Ideal body weight = (Height cm - 100) x 0.9
- Agreement with written informed consent
Who cannot join
- Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) which affect the ADME of drug
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, Blood system, digestive system, central nervous system, mental disease or malignancy disease.
- Inadequate subject by medical examination(medical history, physical examination,ECG, laboratory test) within 28 days of starting administration of investigational drug
- Inadequate result of laboratory test
- AST or ALT > 1.25 x upper limit of normal range
Show all 19Show fewer
- Total bilirubin > 1.25 x upper limit of normal range
- Abnormal level of WBC, Platelet, Hemoglobin WBC < 3.5 x 1000/µL PLT < 100 x 1000/µL Hemoglobin < 11g/dL
- Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
- HGPRT(Hypoxanthine-guanine phosphoribosyl-transferase)deficiency patient such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome
- Severe renal dysfunction: Creatinine clearance less than 50ml/min by cockroft-Gault calculation
- Subject with known for hypersensitivity reaction to mycophenolic acid and mycophenolate mofetil analog
- Previously participated in other trial within 60 days
- Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1month or with may affect the clinical trial within 10 days
- Unusual diet may affect the ADME of drug
- Not able to taking the institutional standard meal
- Previously make whole blood donation within 60 days or component blood donation within 20 days
- Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) and during clinical trials can not be drunk or severe heavy smoker (cigarette > 1/2 pack per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers
The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers.
Read the detailed description
Healthy volunteers are administrated single-dose over the period I and II (Crossover) of CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg.
Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests respectively.
- Conditions
- Healthy
- Being tested
- CKD-4101 tablet, Mycophenolate Mofetil capsule
- Keywords
- Pharmacokinetics, Healthy volunteers, Mycophenolate Mofetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-4101 tabletDrug
CKD-4101 tablet 1000 mg
- 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)
Mycophenolate Mofetil capsuleDrug
Mycophenolate Mofetil capsule 1000 mg
- 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)
| Study group | Role | What they receive |
|---|---|---|
| CKD-4101 tablet | Experimental | Not described Receives: Drug: CKD-4101 tablet |
| Mycophenolate Mofetil capsule | Active comparator | Not described Receives: Drug: Mycophenolate Mofetil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.
Measured: 0-48 hrs
Secondary outcomes (1)
To evaluate the safety of CKD-4101 tablet and Mycophenolate Mofetil capsule from vital signs, physical exam, ECG, laboratory test, adverse event and so on.
Measured: 0-48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ji Young Park, Principal investigator, jypark21@korea.ac.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016626
- Sponsor's protocol ID
- CKD-123HPS08E
- Other IDs
- 123HPS08E
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01016626
- Acronym / sponsor ID
- CKD-123HPS08E
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Healthy volunteers, Mycophenolate Mofetil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers.
Detailed description
Healthy volunteers are administrated single-dose over the period I and II (Crossover) of CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg.
Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-4101 tablet | Experimental | Drug: CKD-4101 tablet |
| Mycophenolate Mofetil capsule | Active comparator | Drug: Mycophenolate Mofetil capsule |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 20 aged and 45 aged in healthy males
- Weight more than 45 kg, IBW ± 20% within the range
- Agreement with written informed consent
Key exclusion criteria (19 listed)
- Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
- Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) which affect the ADME of drug
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, Blood system, digestive system, central nervous system, mental disease or malignancy disease.
- Inadequate subject by medical examination(medical history, physical examination,ECG, laboratory test) within 28 days of starting administration of investigational drug
- Inadequate result of laboratory test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-4101 tabletCKD-4101 tablet 1000 mg * 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover) | Drug | CKD-4101 tablet |
| Mycophenolate Mofetil capsuleMycophenolate Mofetil capsule 1000 mg * 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover) | Drug | Mycophenolate Mofetil capsule |
Primary outcome
To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.
Time frame: 0-48 hrs
1 secondary outcome
To evaluate the safety of CKD-4101 tablet and Mycophenolate Mofetil capsule from vital signs, physical exam, ECG, laboratory test, adverse event and so on.
Time frame: 0-48 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Young Park principal investigator
jypark21@korea.ac.kr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKD-4101 tablet and Mycophenolate Mofetil capsule in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule. (time frame: 0-48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2009.